From offices to laboratories to the hospital floor, University of Virginia Health System officials dropped their sometimes competing interests to help place their COVID-19 patients in studies that had the potential of giving them a better chance of surviving the disease.
UVa patients were eligible early in the virus’ first wave for treatments through studies that included the recently approved drug remdesivir, other drugs, plasma containing COVID antibodies and treatment with stem cells.
“When the pandemic first started, the Health System leadership realized there was a lot of opportunity to do research and studies but that we had a duty to use our resources wisely,” said Dr. Linda Duska, associate dean for clinical research at the UVa School of Medicine.
“We wanted to put into practice a way to get our patients the opportunity to participate in as many studies as possible, but to make sure that those studies would benefit them,” she said. “We needed to make sure the studies fit the patients.”
For Dr. Kyle Enfield, medical director for the UVa hospital’s intensive care unit and a specialist in treating acute respiratory distress syndrome, the question was how to make studies fit with caring for patients critically ill with a disease about which next to nothing was known.
“We needed to take care of the patients on the front lines first,” he said. “At the same time, we needed to find better ways to care for them and what could help them, and that’s why research was important.”
What they did was develop a series of committees that looked at proposed trials and studies, available funding and staffing needs to determine if the research likely would benefit patients and if critical care teams had time and resources enough to implement it.
The goals were to keep patients as safe as possible, stick to best practices and reinforce medical ethics.
“That’s what made this unique. The difference is we have collaboration where the researchers are working with the clinicians on the front lines and the leadership to make decisions,” Enfield said. “We looked at all aspects, from the resources the studies take to the goals, and the pragmatic aspects of whether we can do it and still provide quality care.”
Enfield said having different types of experts on the committees helped staff to implement study protocols without interrupting patient care.
“We knew we could provide really good critical and clinical care but we had nothing to provide patients with in this particular disease,” he said. “There are always a lot of competing interests but we realized we had to work together. We knew we couldn’t compete with each other because we had limited resources and we needed to provide a high standard of care to the patients.”
Enfield said he believes feedback from caregivers has helped to improve research protocols.
“It’s helped researchers form the questions better. When we say, ‘we can’t do that many blood draws and still take care of everyone we need to take care of,’ they can look and see if that’s something they can do in another way or combine blood tests,” he said. “It’s helped us out, the researchers out and the patients.”
With the committees and process in place, the team was ready. Within 10 days of the first patient’s admission to UVa Medical Center with a COVID-19 diagnosis, the first trial for the antiviral remdesivir was up and running in the hospital.
The study was conducted in three waves: the drug against a placebo; the drug plus an approved treatment for rheumatoid arthritis against the drug and a placebo; and a study where the drug was combined with a treatment used for multiple sclerosis against the drug and placebo combination.
The UVa study, and similar studies at other hospitals across the country, continued through the summer. On Oct. 22, the U.S. Food and Drug Administration approved the drug, also known by its trade name Veklury, for use in patients 12 and older and weighing at least 90 pounds.
The committees also sought to bring racial equity into the studies. They wanted the participants in the studies to accurately reflect the patients they were treating on the hospital wards and intensive care units.
It worked. An estimated 57% of hospitalized patients agreed to participate in a study. Of those, 23% were Black and 31% were Hispanic/Latino. Of patients hospitalized for COVID-19 at UVa, 28% are Black and 22% are Hispanic/Latino.
“We’ve been able to offer clinical trials to all eligible patients. We enrolled a large number of Black and Hispanic patients in our trials, and our enrollment for Blacks and Hispanics pretty much matches the percentages that we see in the units,” Duska said. “Nonwhite people are disproportionately affected by this virus and need access.”
“The fact that we were able to recruit so many is amazing,” Enfield said. “There is a long history of mistrust of medicine in those communities. The fact that we’ve been able to improve on that is good. I’m really proud that we’ve been able to do this in a way that really works well for our patients.”
With several studies competing for participants, hospital staff was faced with the problem of how to sign up which patients for which study. In a world of computerized statistical analysis and cross-comparison matrices, they went old school.
“We went with the calendar,” Enfield said. “In a hospital setting, you never know how things are going to go. One day you may have zero patients come in the door and the next you have three and the next 10 and the next zero. If you take seven days in a row, you spread out those zero days. So you enroll people one week in one study. The next week you enroll new patients in another. When one study shuts down, another opens up.”
Although the number of studies has been limited, Enfield and Duska believe their patients have been well served.
“We recognize we’re not New York City. We have a lower volume of patients, and that’s good,” Duska said. “Because of that, we choose the studies we commit to very carefully. We’ve been able to provide scientific data other universities were not. We develop our studies to focus on our strengths.”
Duska said clinical research doesn’t make money but the results pay off in better care and better outcomes. Enfield agrees.
“When you participate in a study, you’re getting something new and different that we think could provide some benefit. Without participation, we don’t really know for sure how well it is working.” he said.
“We need clinical trials. Otherwise, we just don’t have the information, and that’s what drives medical care,” Enfield said. “There’s only so far you can go with computer screens and some cells in a petri dish.”